BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE PUMP INFUSION SET

    MDR report key: 22355548 · Received June 30, 2025

    Report

    Report Number
    9616066-2025-01775
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    May 29, 2025
    Report Date
    August 7, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403227998
    PMA / PMN Number
    K221327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    TWO USED SAMPLE MODEL: 2426-0007, LOTS: 25033010 AND 25033144 AND ONE UNOPENED SAMPLE LOT: 25033144 WERE RETURNED FOR INVESTIGATION. NO DEFECTS OR ABNORMALITIES WERE OBSERVED DURING THE VISUAL INSPECTION FOR THE USED SAMPLE LOT: 25033144. THE SET WAS PRIMED WITH WATER AND A LEAK COMING FROM THE TOP OF THE SILICONE SEGMENT. VISUAL INSPECTION UNDER THE MICROSCOPE SHOWED A PINHOLE AT THE LOCATION OF THE LEAK. THE CUSTOMER COMPLAINT WAS VERIFIED. THE ROOT CAUSE OF THE FAILURE IS LIKELY THAT THE INFUSION SET WAS IMPROPERLY LOADED CAUSING DAMAGE TO THE SILICONE TUBING OF THE PUMPING SEGMENT. SIMILAR FAILURES OF THIS TYPE HAVE BEEN SEEN WHEN THE INFUSION SET IS IMPROPERLY INSERTED INTO THE ALARIS PUMP. WHEN INCORRECTLY LOADING THE INFUSION SET AND CLOSING THE DOOR OF THE ALARIS PUMP, TEARS AND HOLES IN THE SILICONE PUMPING SEGMENT CAN EASILY BEEN CREATED. THE TUBING WAS SEPARATED FROM THE INLET PORT OF THE Y-SITE JUST BELOW THE PUMPING SEGMENT FOR USED SAMPLE LOT: 25033010. THE CUSTOMER COMPLAINT WAS VERIFIED AND A QUALITY NOTIFICATION WAS SENT TO THE MANUFACTURER. NO DEFECTS OR ABNORMALITIES WERE OBSERVED FOR THE UNOPENED SET. THE SET WAS PRIMED WITH WATER AND NO SEPARATION OR LEAKAGE WAS OBSERVED. THE CUSTOMER COMPLAINT WAS UNABLE TO BE REPLICATED FOR THIS UNUSED SAMPLE. THE INVESTIGATION IDENTIFIED THE FOLLOWING POTENTIAL ROOT CAUSES FOR THE LEAKAGE BETWEEN THE TUBE AND SMART SITE ARM COMPONENT: BUSHING WAS PLUGGED OR PARTIALLY PLUGGED DUE TO ADHESIVE AND TUBE RESIDUE. MALFUNCTION IN THE MEDICA ADHESIVE DISPENSING SYSTEM, RESULTING IN NO SOLVENT BEING DISPENSED. ASSEMBLY PROCEDURE WAS NOT FOLLOWED BY THE PERSONNEL INVOLVED IN THE OPERATION. A QUALITY ALERT WAS ISSUED TO RAISE AWARENESS AMONG ALL PERSONNEL INVOLVED IN THE AFFECTED OPERATIONS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT EXPERIENCING ISSUES WITH ALARIS/BD PRIMARY TUBING, REF (B)(4), BREAKING AT THE CONNECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860644 BD ALARIS SMARTSITE PUMP INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 25033010 10885403227998

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown